Study of CP-675,206 in Refractory Melanoma

Refractory Melanoma Clinical Trial

Official title:

A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254579
• Other study ID #: A3671008
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2005
• Last updated: June 5, 2012
• Start date: December 2005
• Est. completion date: December 2009

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgically incurable Stage III or IV melanoma

• One prior systemic treatment for metastatic melanoma

• Measurable disease

• Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1

Exclusion Criteria:

• Melanoma of ocular origin

• Received prior vaccine

• Received prior CTLA4-inhibiting agent

• History of, or significant risk for, chronic inflammatory or autoimmune disease

• Potential requirement for systemic corticosteroids

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Refractory Melanoma

Intervention

Drug:
• CP-675,206
15 mg/kg Q12W dosing regimen

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad de Buenos Aires	Buenos Aires
Australia	Research Site	East Melbourne	Victoria
Australia	Research Site	Nedlands	Western Australia
Australia	Research Site	Waratah	New South Wales
Australia	Research Site	Westmead	New South Wales
Australia	Research Site	Woolloongabba	Queensland
Canada	Research Site	Hamilton	Ontario
France	Research Site	Lille	Cedex
France	Research Site	Paris Cedex 13
France	Research Site	Villejuif
Germany	Research Site	Berlin
Germany	Research Site	Frankfurt
Germany	Research Site	Kiel
Germany	Research Site	Tuebingen
Italy	Research Site	Meldola, FC
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Milano
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Pamplona	Navarra
Spain	Research Site	Zaragoza
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Newcastle Upon Tyne
United Kingdom	Research Site	Newcastle upon Tyne	Tyne and Wear
United Kingdom	Research Site	Northwood	Middlesex
United Kingdom	Research Site	Sutton	Surrey
United Kingdom	Research Site	Truro	Cornwall
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Aurora	Colorado
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bentonville	Arkansas
United States	Research Site	Bethlehem	Pennsylvania
United States	Research Site	Boston	Massachusetts
United States	Research Site	Buffalo	New York
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Chicago	Illinois
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Durham	North Carolina
United States	Research Site	Fayetteville	Arkansas
United States	Research Site	Federal Way	Washington
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Lakewood	Washington
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Madison	Wisconsin
United States	Research Site	Nashville	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Ocoee	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Seattle	Washington
United States	Research Site	Seattle	Washington
United States	Research Site	Stamford	Connecticut
United States	Research Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma		Tumor response is assessed every 2-3 months until disease progression	No
Secondary	Safety		At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug	No
Secondary	Pharmaco Kinetic		At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug	No
Secondary	Survival		At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug	No
Secondary	Health-related QoL		At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug	No